Title : Final Inspection of Lactated Ringer's Resuscitation Fluid, Intravenous Sodium Chloride Solution, and Sodium Chloride-Glucose Solution Used in the Deglycerolization of Human Red Cells Frozen With 40% W/V Glycerol, Produced by the Sterimatics EDM Reflups System and Stored for 8 Months to 2.3 Years.

Abstract : The Naval Blood Research Laboratory, Boston, MA, inspected solutions produced by the EDM REFLUPS system contained in overwrapped plastic bags and stored in a temperature- and humidity-controlled environment for 8 months to 2.3 years. The presence of mold, breakage and leaks was evaluated, and fluid volumes were measured. Lactated Ringer's solution, sodium chloride solution, and red cell wash solution were manufactured at four locations: Naval Ocean Systems Command, San Diego, CA, aboard the USS WASP, U.S. Army Test Site, Fort Sam Houston, San Antonio, TX, and the Naval Blood Research Laboratory, Boston, MA. Of the 7068 bags inspected, 346, or 4.9% had mold present, and in 55 of these bags, the mold was located at the ports. It was noted that the ports were loose on several of the bags. The incidence of mold was found to be related to the site of production and, therefore, to the conditions under which the solutions were produced. Moisture was present beneath the overwrap in 0.6% of the bags, and identified as a leak in slightly less than half of these bags. The fluid volumes in the bags without overwraps averaged 10 ml lower than the bags with overwraps, indicating leakage into the space between the bag and overwrap. Our findings indicate that the potential for contamination during application of the overwrap is a problem that must be resolved at the production site and the integrity of the bag ports must be ensured.